Intra-oral electroencephalography device and method

ABSTRACT

A mouthpiece for being worn on the upper dentition of a user includes electrodes and a microprocessor that operate as an electroencephalograph for detecting electrical activity in the user&#39;s brain. The mouthpiece may be useful in a variety of applications, such as athletics, gaming, and personal hobbies.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-in-Part of U.S. application Ser. No.16/673,077 filed Nov. 4, 2019, which is a Continuation-in-Part of U.S.application Ser. No. 16/202,204 filed Nov. 28, 2018, which is aContinuation-in-Part of U.S. application Ser. No. 15/479,737 filed Apr.5, 2017, which claims the benefit of U.S. Provisional No. 62/319,443filed Apr. 7, 2016. Each of these applications are incorporated hereinby reference in its entirety.

BACKGROUND

Sleep apnea is a common medical condition during which a personexperiences one or more pauses in breathing, and in some instances,experiences shallow breaths during sleep. While there are several typesof sleep apnea, the most common type is obstructive sleep apnea. In thismedical condition, one or more of the person's throat muscles relaxduring sleep causing surrounding tissues in the posterior portions ofthe mouth, nose and throat to collapse, thereby creating a pharyngealobstruction that can block the upper airway. Persons suffering fromobstructive sleep apnea have inadequate oxygen exchange during sleep,which can lead to daytime fatigue, lack of concentration and moodchanges. Left untreated, obstructive sleep apnea can have a significantimpact on a person's health, often leading to cardiovascular, stroke andmetabolic disorders.

Known methods for treatment of obstructive sleep apnea include bothsurgical and nonsurgical devices. A popular surgical procedure isuvulopalatopharyngoplasty, which may be performed for patients who haveanatomical abnormalities that cause their obstructive sleep apnea and/ormake them less likely to tolerate nonsurgical devices.Uvulopalatopharyngoplasty may be a complicated surgery, during which aportion of the soft palate is removed in an effort to prevent closure ofthe airway by excess tissue during sleep. A disadvantage of thisprocedure, however, is that the operation is often expensive and maydamage throat muscles necessary for swallowing and/or cause otherundesirable disorders, such as, nasal regurgitation and numbness of thelower front teeth.

To reduce this risk, various nonsurgical approaches have been employed.One such nonsurgical approach includes using standardized oralappliances to incrementally advance and/or protrude the mandible (lowerjaw) relative to the maxilla (upper jaw). These standardized oralappliances, commonly referred to as a mandibular advancement device,(“MAD”), typically include upper and lower dental trays, whereby thelower dental tray is designed to advance the mandible, and hence, movethe tongue forward to increase the space in the posterior part of thethroat and the oropharynx, which in turn may serve to increase the flowof air during sleep. The distance (degree of advancement) required toprotrude and/or reposition the mandible may be, at least in part,dependent on the severity of the individual's obstructive sleep apnea,as well as psychological variables among the users. A disadvantage ofusing these standard oral appliances is that they may not sufficientlyprovide for and/or address individualized anatomical variances, such asdifference in dental arches, dentition alignment and/or jaw flexibility.Another disadvantage is that in instances where the degree ofadvancement is excessive, the appliance may lead to long-termtemporomandibular joint (“TMJ”) disorders, muscular aggravation,dentition discomfort and/or myofascial disorders. As a result, use ofthese standard appliances has an approximate compliance rate of 75% overa 2-year period. For a detailed study of compliance with use of MAD, seeNon-CPAP therapies in obstructive sleep apnoea: mandibular advancementdevice therapy, see Eur Respir J 2012; 39: 1241-1247, which isincorporated by reference in its entirety. Thus, such oral appliancesmay not treat obstructive sleep apnea in a manner that prevents and/orlimits impacts on a person's health.

FIG. 1 depicts a system 1 including an intraoral stimulator device 2used for providing treatment of a sleep disorder. The intraoralstimulator device 2 is powered by a rechargeable battery and includes ahousing of a hollow dental retainer wireframe or mouthguard (in the caseof a bilateral configuration) or a molar teeth clip (in the case ofunilateral configuration) for positioning on the lower teeth. Thehousing 4 includes a single pair or two pairs of bilateral electrodes 5a, 5 b for positioning ventral-laterally and sublingually at theposterior to middle section under the tongue for recruiting a largesection of the genioglossus muscle and base-of-tongue for stimulation toregain muscle tone during sleep. The system 1 includes an externalinductive recharger sub-system 6, configured to receive electrical powerfrom a wall outlet 7 and use the electrical power to recharge arechargeable battery (not shown) provided in the intraoral stimulatordevice 2 by transferring power through electromagnetic induction.

The oral appliance 1 further includes a non-rechargeablebattery-operated hand-held appliance 3 that communicates instructions tothe intraoral stimulator device 2. The non-rechargeable battery-operatedhand-held appliance 3 is used by the patient's sleep medicine physicianto program the stimulation and to set system parameters in the intraoralstimulator device 2. The stimulation can be pre-programmed or can occuras a result of change in the user's breathing pattern, as tested byaccelerometer, temperature, piezoelectric film and EMG. Alternatively,the stimulation therapy may be programmed and setup up by a physician sothat the therapy begins as soon as the device is turned On and ceaseswhen the device turns Off, without regard to changes in the user'sbreathing pattern. An issue with continuous stimulation is that overstimulation can lead to nerve and/or muscle fatigue/damage. Moreover,while a physician can set and/or send instructions to the intraoralstimulator, the physician cannot store and or assess the breathingand/or snoring pattern of a patient in a way that allows the physicianto modify treatment as may be necessary. The lack of specializedtreatment measures in individual patients with unique medical needs canbe problematic, particularly because they fail to store patient behaviorand/or medical data that can assist medical providers in the designand/or improvement of specialized treatment measures for individualpatients. Thus, such intraoral stimulator devices may fail to treatobstructive sleep apnea in a manner that prevents and/or limits impactson a person's health.

Other methods of treating obstructive sleep apnea include theadministration of positive air pressure via a continuous positive airwaypressure (“CPAP”) machine. The CPAP machine is often assembled for usein combination with various face or nasal masks and may providecontinuously pressurized and/or forced air during the person's sleep. Adisadvantage of this assembly is that it may cause nasal and/or oralmucosal dryness due to the continuously forced air and may also causeclaustrophobia due to the presence of a mask on the patient's face. As aresult, use of these assemblies has an approximate compliance rate of50% over a 5-year period. For a detailed study of compliance with use ofCPAP machines, see Long-term compliance with continuous positive airwaypressure in patients with obstructive sleep apnea, Can Respir J. 2008October; 15(7): 365-369, which is incorporated by reference in itsentirety. Another disadvantage is that standard masks are not properlyadapted for a customized fit for persons with unique and/or variablefacial anatomies that may be natural or created by loss of muscle tonesecondary to facial paralysis and/or stroke. Ill-fitting masks may leadto leakage of air and/or inadequate air intake. In addition, the masksused with CPAP machines have been found to be a breeding ground forbacteria and fungi. Despite routine washing and cleaning measures, thebacteria and fungi on these masks can grow exponentially, and lead toinfections, such as pneumonia, in the airways of persons who use them.Moreover, such assemblies may not sufficiently treat obstructive sleepapnea and may fail to promote patient compliance with the treatmentmethod.

The aforementioned treatment techniques may not provide sufficienttreatment of obstructive sleep apnea, may cause and/or promote othernegative health situations for the user and may not foster compliancewith treatment methods.

In view of the disadvantages associated with currently available methodsand devices for treating obstructive sleep apnea, there is a need for adevice and method that treats obstructive sleep apnea while storingpatient behavior and/or medical data relating to a user's breathingpattern, snoring pattern and/or clenching/grinding behaviors, that canassist medical providers in the design, improvement and/or modificationof specialized treatment measures for individual patients. Further,there is a need for a device and method that treats obstructive sleepapnea in a single removable oral appliance and prevents and/or limitslong-term TMJ disorders, muscular aggravation and/or myofascialdisorders that may occur with continued use of currently availableappliances.

Electroencephalography is a technique for recording and interpretingelectrical activity occurring within the brain. The EEG technique isbased on the nerve cells of the brain generating electrical impulsesthat fluctuate in particular patterns. The pattern produced by anelectroencephalograph machine, which may be recorded, is called anelectroencephalogram (EEG).

Obtaining an EEG typically begins with the attachment of a number ofpairs of electrodes to the subject's scalp. Each pair of electrodessends a signal to one of several recording channels of theelectroencephalograph; the signal is a measure of the voltage differencebetween the pair. This voltage difference can be rhythmic and shown aswaves on a line graph by the recording channel. For a normal, fullyconscious adult in a relaxed state, the EEG shows regularly oscillatingwaves known as alpha waves. Subjecting the person to excitement orstartling the person results in the alpha waves being replaced by rapidirregular waves of low-voltage relative to the alpha waves. A sleepingadult's brain waves become extremely slow. This is also true for aperson in a coma. Other abnormal conditions have known EEG patterns. Forexample, delta waves are irregular slow waves in the vicinity of an areaof brain damage. Although certainly not useful in all circumstances,electroencephalography has been useful as a diagnostic aid in cases ofserious head injuries, brain tumors, sleep disorders, cerebralinfections, epilepsy, some degenerative diseases of the nervous systemand brain death.

In a sleep lab, delta waves may be utilized to assess the depth ofsleep. The stronger the delta rhythm, the deeper the sleep. Increaseddelta power (an increased quantity of delta wave recordings) has alsobeen found to be associated with increased concentration on internalworking memory tasks.

As noted, collection of EEG data is performed with electrodes attachedto the subject's scalp. One reason for this placement is to have theelectrodes as close as possible to the brain with as little interveningstructure as possible. Other than for bald subjects, it is not possibleto really ‘attach’ electrodes to the scalp. This presents a problembecause movement of electrodes can interfere with the quality of thereceived voltages. In addition, since muscle cells also generate anelectrical potential, electroencephalograph machines typically try toavoid muscles intervening between the electrode and the brain.

In addition to above, there is a need for a device and method capable ofdetermining when a user is having arousals or being awoken from deepsleep, entering or in an obstructive sleep apnea condition. Such amonitoring device and method may be coupled with active treatmentregimens. That is, a determination made that the user is being awokenfrom or having arousals from sleep, entering or in an obstructive sleepapnea condition may be used a trigger for the active treatment regimens.

BRIEF DESCRIPTION

According to an aspect, the present embodiments are associated with anoral appliance for treatment of sleep apnea in a user. The presentembodiments may comprise a mouthpiece configured to be retained in themouth of the user, a plurality of electrodes, a microprocessor and atleast one stimulator. The mouth of the user contains oral tissue and themouthpiece has a lingual wall and a buccal wall. A plurality ofelectrodes are attached to the mouthpiece and electrically connected tothe microprocessor; the electrodes and microprocessor are configured todetermine electroencephalograph rhythms of the user's brain. Themicroprocessor is configured to assess the rhythms for an immediatepresence of sleep apnea in the user. The at least one stimulator is alsoattached to the mouthpiece and is configured to respond to the immediatepresence of sleep apnea in the user by stimulating the user'sgenioglossus. The oral appliance mouthpiece may have an upper portionand a lower portion.

Embodiments of the disclosure are further associated with an oralappliance for treatment of sleep apnea in a user comprising amouthpiece, a plurality of electrodes, at least one electricalstimulator, a microprocessor. The mouthpiece is configured to beretained in the mouth of the user and may have an upper portion and alower portion, each with a lingual wall and a buccal wall. The mouth ofthe user has oral tissue. The plurality of electrodes are attached tothe mouthpiece and the microprocessor is configured to receive signalsfrom the electrodes such that the electrodes and microprocessorcumulatively operate as an electroencephalograph and detect electricalrhythms from the user's brain. The electrical rhythms may be indicativeof an immediate presence of arousals from deep sleep, or the presence ofsleep apnea in the user. The at least one electrical stimulator isattached to the mouthpiece and microprocessor; the stimulator isconfigured for emitting an electrical current or field in response tothe immediate presence of sleep apnea in the user based on theelectrical rhythms.

Embodiments of the disclosure are further associated with a mouthpiecefor being worn on the upper dentition and jaw (or upper jaw, withoutteeth) of the user. The mouthpiece includes electrodes that detectelectrical rhythms of the user's brain. The mouthpiece may be useful ina variety of applications, such as athletics, gaming, and personalhobbies. It is contemplated that the mouthpiece may be used to detect,in real time, traumatic blows to the head of a user during an athleticactivity, to be detected in real time, while the athlete wears the uppermouthpiece. The user's EEG can also be monitored on the side lines bytrained operators. This technique may detect early onset of acute braintrauma or concussion prior to any clinical presentations and help savethe user from potential future damaging side effects of the trauma.

BRIEF DESCRIPTION OF THE FIGURES

A more particular description will be rendered by reference to specificembodiments thereof that are illustrated in the appended drawings.Understanding that these drawings depict only typical embodimentsthereof and are not therefore to be considered to be limiting of itsscope, exemplary embodiments will be described and explained withadditional specificity and detail through the use of the accompanyingdrawings in which:

FIG. 1 is a perspective view of a prior art oral device;

FIG. 2 is a top view of an oral appliance, according to an embodiment;

FIG. 3 is a perspective view of an oral appliance, according to anembodiment;

FIG. 4 is a perspective view of an oral appliance, according to anembodiment;

FIG. 5 is a perspective view of an oral appliance kit, according to anembodiment;

FIG. 6 is a schematic of a method for providing electrical genioglossusstimulation, according to an embodiment;

FIG. 7 is a bottom view of a top mouthpiece oral appliance, according toan embodiment;

FIG. 8A is a bottom, left-side perspective view of the mouthpiece oralappliance, according to an embodiment;

FIG. 8B is a bottom, right-side perspective view of the mouthpiece oralappliance shown in FIG. 8A;

FIG. 9 is a bottom, anterior perspective view of the mouthpiece oralappliance, according to an embodiment; and

FIG. 10 is a schematic of a method for providing electrical genioglossusstimulation, according to an embodiment.

Various features, aspects, and advantages of the embodiments will becomemore apparent from the following detailed description, along with theaccompanying figures in which like numerals represent like componentsthroughout the figures and text. The various described features are notnecessarily drawn to scale but are drawn to emphasize specific featuresrelevant to some embodiments.

DETAILED DESCRIPTION

Reference will now be made in detail to various embodiments. Eachexample is provided by way of explanation and is not meant as alimitation and does not constitute a definition of all possibleembodiments.

Embodiments of the disclosure relate generally to devices/appliances andmethods for treating obstructive sleep apnea, a device for providingelectrical stimulation to a user's tongue to inhibit and/or limitsnoring that may be caused by obstructive sleep apnea as well as adevice including a pharmaceutical delivery reservoir for delivery of adrug for treating obstructive sleep apnea. Such devices provideparticular utility in providing electrical stimulation to the user'stongue in such a manner that the stimulation does not awaken the userduring sleep. Alternatively or supplemental to electrical stimulation,the device may include a pharmaceutical compound, such as an ionizedmedication, that treats obstructive sleep apnea. The pharmaceuticalcompound may be provided in a reservoir/pharmaceutical reservoir,separate from the device, or as part of the physical matrix of thedevice. Particularly in the former option, the reservoir may be refilledor replaced on a daily or less frequent schedule.

The oral appliance contemplated includes a mouthpiece that is configuredto receive at least temporary, permanent and/or artificial lowerdentition of the user. The mouthpiece may include various electroniccomponents including one or more of the following: an oxygen sensor, apressure sensor, an airflow sensor, a noise detector, an actigraphysensor, a stimulator, data recorder, battery and a microprocessor. Themouthpiece may also be comprised of a material, e.g., a polymer matrix,into which a pharmaceutical compound may be incorporated for delivery tothe user. Alternatively, one or more reservoirs containing apharmaceutical compound may be attached to the mouthpiece. Eachreservoir is capable of delivering a drug directly to one or more oralcavity membrane surfaces of the user. The mouthpiece may includecustomizable materials that provide a comfortable fit for a user whileretrieving data related to the user's oxygen saturation levels,clenching and/or grinding of dentition surfaces, actual airflow levelsand noise levels associated with snoring, analyzing the data, andpreparing a set of instructions to the stimulator.

When utilized in combination with a pharmaceutical compound, thestimulator components may be utilized to effect transfer of the drugfrom the device to the oral mucosa of the user. This drug deliveryfunction may be in addition to the electrical stimulation of a user'soral musculature or may be alternative thereto, i.e., the electricalstimulation may only function as a drug release/delivery mechanism. Thestimulators may operate to rupture or pierce the pharmaceuticalreservoir(s) attached to or otherwise associated with the mouthpieceupon receiving and instruction to do so. Alternatively, the stimulatorsmay be utilized in combination with pharmaceuticals bearing anelectrically charged surface, as will be further explained. In the eventthat the microprocessor sends a signal resulting in the rupture ofpharmaceutical reservoir(s), notification of the user that the reservoiris in need of replacement can be conveyed by the microprocessor to theuser. Such notification may take the form of a smartphone notificationof the user or visual notification, e.g., activation of LED light whenuser is next able to see said light.

According to an aspect, the mouthpiece is customized to be receivablypositioned and/or secured on the mandible of the user. According to anaspect, the mouthpiece is customized to receive the lower dentition ofthe user. In any event the mouthpiece may be customized such that itprovides a comfortable fit that enhances the user's comfort andreinforces the user's likelihood of repeated wear of the mouthpiece,i.e., the user's compliance rate.

For purposes of illustrating features of the embodiments, embodimentswill now be introduced and referenced throughout the disclosure. Thoseskilled in the art will recognize that this example is illustrative andnot limiting and is provided purely for explanatory purposes.

In an embodiment, and with particular reference to FIGS. 2-4, an oralappliance 10 for treatment of sleep apnea in a user is provided. Theoral appliance 10 is illustrated as having a mouthpiece 20 and severalcomponents. In an embodiment, the mouthpiece 20 is “customizable”, thatis, customized to the individual user's mouth in such a manner that itprovides for a comfortable fit over and around surfaces of the user'shard (teeth/dentition) and/or soft tissues (general mouth structure,including gums). When customized, the mouthpiece 20 may fit overtemporary, permanent, primary natural and/or artificial lower dentitionof adult and/or child users. The mouthpiece 20 may be configured toreceive a removable denture of the user. According to an aspect, themouthpiece 20 is fabricated over the lower jaw, that is, the mandible,with partial or complete absence of dentition. When customized, themouthpiece 20 can be formed of any self-conforming material that may beadaptable to variances and/or changes in mouth structure, or through useof a dental impression of the individual user's dentition, as would beunderstood by a person having ordinary skill in the art. In other words,a mandibular impression and/or a dental impression can be taken, wherebya negative imprint of the user's hard and/or soft tissues are used tocreate a positive reproduction (or cast) customized for the user.

The types of materials selected to form the mouthpiece 20 would be knownto one of ordinary skill in the art and includes polymers,thermoplastics, acrylics, silicone, rubber, metal wires or any othermaterial that can be used to form the mouthpiece 20 conformed to theuser's dentition. In an embodiment, the materials are medical-grade,latex-free, BPA-free and any other material known to minimize patienthealth risks. According to an aspect, the mouthpiece 20 may be formedfrom the impression made in a thin, resilient material. The mouthpiecematerial may also be selected, particularly from polymers, for itsability to have a pharmaceutical compound incorporated within thestructural matrix.

In an embodiment and as illustrated in FIGS. 2 and 3, the mouthpiece 20includes a central channel 29 bounded by a lingual portion 24 and abuccal portion 23. The central channel 29 may be configured to bereceivably positioned over and/or receive one or more of the user'sdentition such that the mouthpiece 20 is secured thereon. When themouthpiece 20 is in use, the central channel 29 may receive the user'sdentition and may extend over and/or cover occlusal or bite surfaces ofthe user's teeth. The lingual portion 24 of the mouthpiece 20 extendsbetween the user's teeth and the user's tongue. In an embodiment and asillustrated in FIGS. 2 and 3, the buccal portion 23 of the mouthpiece 20extends between the user's teeth and the user's cheek.

According to an aspect, the mouthpiece 20 is configured to be secured tothe user's dentition. In an embodiment and as illustrated in FIG. 4, themouthpiece 20 includes the lingual portion 24 and dentition attachmentmembers 28 coupled to the lingual portion 24. The dentition attachmentmembers 28, as well as the lingual portion 24, may be customizable, suchthat the dentition attachment members 28 have a shape and size thatsubstantially conforms to the dentition of the user, thereby providingthe user with the mouthpiece 20 having a secured and customized fit.Typically, the dentition attachment members 28 are provided in awire-frame form, in a way that extends from the lingual portion 24 towrap over or around the individual user's dentition and anchor thelingual portion 24 between the lingual surface of the teeth and thetongue. According to an aspect, at least a portion of the dentitionattachment members 28 is shaped to form a retention loop around one ormore teeth of the user.

Similar to the dentition receiving cavities 25 described for themouthpiece 20 of FIGS. 2 and 3, the lingual portion 24 depicted in FIG.4 may also be customized to have a shape that is substantially the sameas the shape of the individual user's dentition for which it has beenmolded and/or shaped to fit, thereby assisting the retention function ofthe dentition attachment members 28. In any event, the mouthpiece 20 iscapable of being at least temporarily fixed in place by virtue of havingbeen molded and conformed to the dentition of the user and/or beingprovided with the dentition attachment members 28, thus providing thecustomized fit. As such, the mouthpiece 20 may provide a retentionfunction thereby allowing the oral appliance 10 to remain in placeduring the user's sleep, particularly in situations where the user maymake slight to moderate movements during sleep and/or when the user maybe awake. Thus, the mouthpiece 20 may be substantially immovable unlesspositive effort is applied to remove the mouthpiece 20. In other words,the user may remove the mouthpiece 20 at any time, if desired, byexerting a little pressure to remove the mouthpiece 20. Since themouthpiece 20 is not permanently affixed to the dentition, it can beworn and/or subsequently removed by the user at any time. Therefore, theoral appliance 10 may be used for varying lengths of time.

According to an aspect and as illustrated in FIGS. 2-4, the componentspositioned on and/or embedded within the mouthpiece 20 include one ormore of the following components: an oxygen sensor 30, a pressure sensor32, an airflow sensor 34, a noise detector 35, an actigraphy sensor 36,a stimulator 40, a pharmaceutical reservoir 42, a microprocessor 50, adata recorder 60 and a battery 70. According to an aspect, themouthpiece 20 includes dry protective areas or covering to theseelectronic components that substantially inhibit and/or limit waterand/or tissue damage to the components (not shown). Such dry/protectedzones may be formed by virtue of the components being embedded withinthe mouthpiece 20 itself.

As illustrated in FIGS. 2-4, the oxygen sensor(s) 30 may be providednear an anterior portion 21 of the mouthpiece 20, i.e., towards theuser's lips and away from the user's pharynx. According to an aspect,the oxygen sensor 30 is configured to monitor and/or determine actualoxygen saturation levels of the user's hemoglobin. The oxygen sensor 30may be adapted to monitor and/determine the pulse and/or heart rate ofthe user. The oxygen sensor 30 may be positioned on or in the lingualportion 24 of the mouthpiece 20. In an embodiment, the oxygen sensor 30is positioned primarily towards lateral portions of the tongue, whichare generally understood to be the most vascular areas of the tongue,i.e., having numerous blood vessels, as well as the buccal regions ofthe upper jaw. According to an aspect, the oxygen sensor 30 is atransceiver such as a pulse oximeter configured to monitor/sense theoxygen saturation level of a user by analyzing the change in color ofthe user's blood. The pulse oximeter may measure the pulse rate of theuser, typically in beats per minute, based on variations and/ordeviations in the user's oxygen saturation level. An exemplary pulseoximeter, for example, may include light emitting diodes configured totransmit red and infrared lights to vascular surfaces of the user'stongue and sense changes in oxygen level in the user's tongue. Accordingto an aspect, two oxygen sensors 30 are provided on the lingual portion24 of the mouthpiece 20. It is contemplated that oxygen sensors 30 maybe placed in other locations of the oral cavity, such as the buccalbone, such that the oxygen sensors gather oxygen saturation data fromthe gum surface overlaying the buccal bone. The two oxygen sensors 30may be bilaterally positioned on the mouthpiece 20. While FIGS. 2-4illustrate two oxygen sensors 30 being positioned on the mouthpiece 20,it is to be understood that the number of oxygen sensors provided may be3, 4, 5, 6 or more.

According to an aspect and as illustrated in FIGS. 2 and 3, the oralappliance 10 may include one or more pressure sensors 32. According toan aspect, the one or more pressure sensors 32 are configured to detectsigns of clenching and/or grinding by the user that occur, for example,while the user is asleep. The pressure sensors 32 may be positioned inor on the central channel 29. In an embodiment, the pressure sensors 32are positioned in the dentition receiving cavities 25, such that thepressure sensors 32 are positioned substantially adjacent to the user'smandibular occlusal and/or bite surfaces. According to an aspect, thepressure sensors 32 are on an exterior surface of the central channel29, where the central channel 29 has an interior surface configured forreceiving the dentition receiving cavities 25 and the exterior surfaceis positioned opposite of the interior surface, such that the pressuresensors 32 are positioned substantially adjacent to the user's maxillaryocclusal and/or bite surfaces. In some embodiments (not shown), thepressure sensors may be provided on the dentition attachment members 28,such as those manufactured by Tekscan under the brand FlexiForce™ ForceSensors. Such signs of clenching may include force sensors configured tomeasure the force that is being applied to occlusal and/or bite surfacesof the user's teeth. According to an aspect, the pressure sensors 32 area thin resilient material. The one or more pressure sensors 32 may beelectrically sealed and/or impervious to liquids, saliva and/or oraltissue. The number of pressure sensors 32 provided on the mouthpiece 20may be selected based on the user's proclivity to grinding and/orclenching. According to an aspect, the number of pressure sensors 32provided is 2, 3, 4, 5, 6 or more.

In an embodiment, the mouthpiece 20 includes one or more airflow sensors34 configured to measure the actual airflow and/or breathing rate of theuser, i.e., the rate of air that is inhaled and/or exhaled through themouthpiece 20 by the user. According to an aspect, the airflow sensor 34is configured to detect any reduction and/or cessation of airflow duringsleep. The airflow sensor 34 may be arranged at any position on themouthpiece 20 that is in a general flow path of air inhaled and/orexhaled by the user. As illustrated in FIG. 2, the airflow sensor 34 maybe positioned near a posterior portion 22 of the mouthpiece 20.According to an aspect, the airflow sensor 34 is bilaterally positionedon the mouthpiece 20. As illustrated in FIGS. 2-3, one airflow sensor 34may be positioned to the left of the lingual portion 24, while anotherairflow sensor 34′ may be positioned to the right of the lingual portion24. In any event, both airflow sensors 34, 34′ may work in tandem tomeasure the user's airflow rate. Airflow sensors 34 may be arrangedin/on at least one of the lingual portion 24 and the buccal portion 23of the mouthpiece 20. The number of airflow sensors 34 provided on themouthpiece may be selected based on the needs of the user. According toan aspect, the number of airflow sensors provided is 2, 3, 4, 5 or more.

According to an aspect and as illustrated in FIGS. 2-4, the mouthpiece20 may include an actigraphy sensor 36 configured to monitor and capturedata related to sleep activity, including sleep position and movement ofthe user during sleep. The actigraphy sensor 36 may embedded in orotherwise connected to the mouthpiece 20, at any desired position.According to an aspect and as illustrated in FIG. 2-3, the actigraphysensor 36 is position at the buccal portion 23 of the mouthpiece 20. Inan alternate embodiment and as illustrated in FIG. 4, the actigraphysensor 36 may be positioned at the lingual portion 24 of the mouthpiece20. The actigraphy sensor 36 may determine the user's sleep positions,such as, for example, a supine position during which the user ispositioned on his/her back, a prone position during which the user islying face down and/or lateral recumbent positions during which the useris lying on their left or right sides. The actigraphy sensor 36 maymeasure the time the user sleeps in each identified position and/or thefrequency of the user changing from one sleep position to another sleepposition.

The oral appliance 10 may include a noise detector 35 configured todetect actual noise and/or vibrations caused by the user's snoring.According to an aspect, the noise detector 35 is internally hard-wiredto one or more components coupled to or otherwise embedded in themouthpiece 20, such as, for example, the stimulator 40, themicroprocessor 50 and the data recorder 60, such that the noise detector40 can communicate with the components. The noise detector 35 may beconfigured to wirelessly communicate with at least one of the stimulator40, the microprocessor 50 and the data recorder 60. The noise detector35 may be positioned on or otherwise embedded in the mouthpiece 20 atany desired location. According to an aspect, the noise detector 35 ispositioned at the posterior portion 22 of the mouthpiece 20, such thatrelevant snoring information may be detected close to a sound source,i.e., the user's pharynx. In an embodiment, the noise detector 34 ispositioned at the anterior portion 21 of the mouthpiece 20. Asillustrated in FIG. 3, the noise sensor 35 may be positioned at thebuccal portion 23 of the mouthpiece 20. In an embodiment and asillustrated in FIG. 4, the noise sensor 35 is positioned at the lingualportion 24 of the mouthpiece 20. While FIGS. 3-4 illustrate a singlenoise detector 35 being provided on the mouthpiece 20, it is to beunderstood that 2, 3, 4 or more noise detectors 35 may be provided.

According to an aspect and as illustrated in FIGS. 2-4, the at least onestimulator 40 is provided near the posterior portion 22 of themouthpiece 20, that is generally near the back of the user's mouth. Thestimulator 40 is configured to provide a gentle stimulation to thetongue of the user, as will be described in more detail hereinbelow. Inan embodiment, the stimulator 40 is positioned on the lingual portion 24of the mouthpiece 20, adjacent to the tongue. The stimulator 40 may bebilaterally positioned on the mouthpiece 20, such that bilateralstimulation may be provided to both sides of the user's tongue. Thestimulator 40 may be positioned substantially adjacent to a base of theuser's tongue, for example, adjacent to the user's genioglossus muscle.Thus, the stimulator 40 may be configured for providing stimulation tothe genioglossus muscle of the user's tongue in a manner that allows themuscle tone of the genioglossus muscle to be regained. Such stimulationmay be electrical impulses that cause the genioglossus muscle tocontract and/or cause the user to reduce the amount of force beingapplied to occlusal and/or bite surfaces of the user's teeth. In someembodiments, contraction of the genioglossus muscle may cause the user'stongue to protrude, thereby creating more space in the user's pharynxand helping the user breathe more easily in a manner that increases theoxygen saturation levels of the user's hemoglobin. The stimulation maybe in response to the actual saturation level of hemoglobin of the user,as measured by the at least one oxygen sensor 30.

According to an aspect, the stimulator 40 is activated based onmeasurements received from the oxygen sensors 30, the pressure sensors32, the airflow sensors 34 and/or the noise detector 35. The stimulator40 may be activated if the oxygen sensor 30 determines that the actualoxygen saturation level of hemoglobin of the user is at a predeterminedoxygen level, that is, that a certain oxygen level has beenpre-determined to be insufficient. The stimulator 40 may provide atleast intermittent stimulation to the genioglossus muscle of the user'stongue until the oxygen saturation level of hemoglobin rises above thepredetermined oxygen level. In an embodiment, the stimulator 40 isactivated if the oxygen sensor 30 determines that the actual oxygensaturation level of hemoglobin of the user is below about 95% oxygensaturation. Stimulation of the user's genioglossus muscle may facilitatean increase in respiratory flow to the user, thereby increasing theavailability of oxygen to the user and the increase of oxygen saturationlevels of hemoglobin. According to an aspect, when the oxygen sensor 30determines that the oxygen saturation level of hemoglobin of the user isabove about 95% oxygen saturation, the stimulator 40 is not activated.In an embodiment, the stimulator 40 is activated if the pressure sensors32 detect grinding and/or clenching by the user. According to an aspect,the stimulator 40 provides stimulation until the force applied toocclusal and/or bite surfaces of the user's teeth are below apredetermined force level. The stimulator 40 may stop stimulation oncethe pressure sensors 32 detect that grinding and/or clenching hassubstantially decreased and/or ceased, as evidenced by the detectedforce level. According to an aspect, the stimulator 40 is activated whenthe airflow sensor 34 determines that the frequency of air inhaledand/or exhaled by the user is below a predetermined airflow level. In anembodiment, the stimulator 40 is activated when the airflow sensor 34determines that airflow is at or below 30% of the user's natural airflowor breathing rate, i.e., air inhaled and/or air exhaled by the userwhile the user is awake (natural airflow), has been reduced by 30%. Thestimulator 40 may provide stimulation to the genioglossus muscle untilthe predetermined airflow level is achieved and/or airflow to the useris at least about 30% of the user's natural airflow rate. In anembodiment, the stimulator 40 is activated if the noise detector 35detects that the actual noise and/or vibrations are above apredetermined noise level. In this embodiment, the stimulator 40provides gentle electrical stimulation to the genioglossus muscle of theuser's tongue until the actual noise and/or vibrations are below thepredetermined noise level.

In an embodiment, the stimulator 40 is configured to provide constantstimulation to the genioglossus muscle of the user's tongue.Alternatively, the stimulator 40 may provide variant stimulation to thegenioglossus muscle of the user's tongue. The variant stimulation mayincreasingly stimulate the genioglossus muscle of the tongue until theoxygen saturation level is at the predetermined oxygen level, such as,for example, at or above 95%. In an embodiment, the variant stimulationincreasingly stimulates the genioglossus muscle until the force appliedto the occlusal and/or bite surfaces is below the predetermined forcelevel. The variant stimulation provided by the stimulator 40 to mayincreasingly stimulate the genioglossus muscle until the predeterminedairflow level is achieved and/or until the actual noise and/orvibrations are below the predetermined noise level. According to anaspect, the strength and frequency of the electrical impulses in variantmode will depend on how quickly the oxygen saturation of hemoglobinand/or the predetermined force level is achieved. The constant orvariant stimulation may be a gentle stimulation that does not disturband/or awaken the user during sleep. According to an aspect, theconstant or variant stimulation is gentle enough so that the user doesnot recognize it when wearing it when the user is at least slightlyawake. The stimulator 40 may alternate between a constant stimulationmode and a variant stimulation mode. In an embodiment, the at least onestimulator 40 is an electrode configured to provide gentle electricalimpulses. The gentle electrical impulses may be provided to thegenioglossus muscle of the user's tongue in a non-invasive manner and insuch a manner that stimulation does not awaken the user during sleep.

In an embodiment, the mouthpiece 20 or structures associated with themouthpiece 20 allow delivery of a pharmaceutical compound to fosterretention or reacquisition of muscle tone of the genioglossus muscle.Such a pharmaceutical compound may cause the genioglossus muscle tocontract. Activation of the genioglossus muscle may be achievedutilizing cholinergic drugs such as neostigmine. Other stimulants and/ordrugs that activate and/or increase calcium ion release/activationaffecting muscle contraction may also be used to activate thegenioglossus muscle, such compounds include norepinephrine and caffeine.

In another embodiment, genetically engineered light stimulation of thenerves and muscles, specific to the desired site, may be utilized. Thisconcept is called optogenetics Optogenetics makes it possible tostimulate neurons with light by inserting the gene for a protein calledchannelrhodopsin-2, from green algae. When a modified neuron is exposedto blue light, the protein initiates electrical activity inside the cellthat then spreads from neuron to neuron. The optical control methodprovides advantages over electrical stimulation for muscle and thebiomechanics of human movement. That is, photons are released by themouthpiece 20 instead of electrical charge/current.

In an embodiment, the pharmaceutical compound may be incorporated intothe material of mouthpiece 20 for active or passive release. Passiverelease may be triggered by environmental factors in the users mouthsuch as change in temperature, pH or similar variables. Active releasemay involve electrical stimulation controlled by the microprocessor 50responsive to inputs from one or more of the sensors associated withmouthpiece 50. Electrical stimulation resulting in drug release isdiscussed further below.

Iontophoresis is a drug delivery process utilizing a voltage gradient.Molecules are transported through a semipermeable material or barrier byelectrophoresis and/or electroosmosis. Electrophoresis is the motion ofcharged particles, ions or anions, in the presence of an electric field.Particles bearing a surface charge present in a liquid or gel, i.e.,capable of substantial movement relative to the medium in which they arecontained, are most amenable to electrophoresis, though movement throughother materials is possible. Electroosmosis is the motion of liquidinduced by an applied electrical potential across a porous material,capillary tube, membrane, microchannel, or any other fluid conduit.Iontophoresis is an active transport of matter resulting from an appliedelectric current. Such transport is measured in units of chemical flux,commonly μmol/(cm²*hour).

The material chosen for mouthpiece 20 may be, for example, a polymeracting as a semipermeable retainer of a selected pharmaceuticalcompound. That is, the material of mouthpiece 20 will retain thepharmaceutical compound under storage and other conditions whilereleasing the pharmaceutical compound under certain passive or activeconditions. In the case of active release, an electric charge orelectric field may be applied to some portion of mouthpiece 20, causingthe pharmaceutical compound to flow out of the mouthpiece 20 and be madeavailable for absorption through the user's oral mucosa precisely to thetissues to which it is designed to treat. Whether released actively orpassively, once a reservoir 42 is empty, notification of the user that areservoir 42 is in need of replacement can be conveyed by themicroprocessor 50 to the user. Such notification may take the form of asmartphone notification of the user or visual notification, e.g.,activation of LED light when user is next able to see said light.Replacement reservoir(s) 42 may be provided to user and have means,e.g., friction or adhesive (e.g., pressure sensitive adhesives/PSA), forattachment to mouthpiece 20 upon notification of the user regarding theneed for replacement.

In an embodiment, a reservoir 42 containing a liquid, gel or similarstate of matter may be associated with the mouthpiece 20. For example,the reservoir 42 may comprise a pouch attached to a surface ofmouthpiece 20 and containing a pharmaceutical compound. In anembodiment, the pouch is formed from a material that will rupture whensubjected to an electric charge or field by activation of stimulator 40.This activation may be the result of microprocessor 31 responding toinput from one or more sensors, as described previously. The reservoir42 pouch will typically be attached to mouthpiece 20 at a surfaceunlikely to bear much force associated with the user's teeth biting orrubbing against one another or the mouthpiece 10. Thus, the lingual wall24 or buccal wall 23 are ideal for placement of reservoir(s) 42. Thereservoir 42 may be removed after use or simply dissolve during use;either way, placement of a new reservoir 42 immediately prior toinsertion of the mouthpiece 20 by the user can be done when needed.

In an embodiment, the material of the pouch walls 44 formingreservoir(s) 42 may be a semipermeable polymer through which thepharmaceutical compound may pass under specified passive conditions orone through which the pharmaceutical may pass when an electricalstimulus or field is applied to the pouch reservoir 42. When electricalstimulus is required for iontophoresis, besides considerations ofreservoir 42 placement discussed above, it is also important to considerplacement relative to electrical stimulator(s) 40. A feature of thestimulating reservoir(s) 42 to dispense the pharmaceutical compound isthat delivery of the compound may be initiated, halted and reinitiatedaccording to readings sensors 30, 32, 34 and/or 36 convey tomicroprocessor 50. Thus, instead of having the pharmaceutical compounddelivered as a bollus, it may be delivered closer to the profile ofuser's need.

Another semi-permeable barrier through which molecules of thepharmaceutical compound may be transported is the outermost layer ofhuman skin, i.e., the stratum corneum and other oral mucosa layers.Thus, however released from mouthpiece 20, the pharmaceutical compoundis absorbed by the oral mucosa of the user. In some embodiments,pharmaceutically induced contraction of the genioglossus muscle maycause the user's tongue to protrude, thereby creating more space in theuser's pharynx and helping the user breathe more easily in a manner thatincreases the oxygen saturation levels of the user's hemoglobin. Thestimulation may be in response to the actual saturation level ofhemoglobin of the user, as measured by the at least one oxygen sensor30. Release of the pharmaceutical compound resulting in stimulation tothe genioglossus muscle of the user's tongue may continue until theoxygen saturation level of hemoglobin rises above the predeterminedoxygen level. In an embodiment, the stimulator 40 is activated if theoxygen sensor 30 determines that the actual oxygen saturation level ofhemoglobin of the user is below about 95% oxygen saturation. Stimulationof the user's genioglossus muscle may facilitate an increase inrespiratory flow to the user, thereby increasing the availability ofoxygen to the user and the increase of oxygen saturation levels ofhemoglobin. According to an aspect, if the oxygen sensor 30 determinesthat the oxygen saturation level of hemoglobin of the user is aboveabout 95% oxygen saturation, stimulator 40 is not activated andreservoir 42 is not caused to dispense the pharmaceutical compoundthrough iontophoresis or otherwise. In an embodiment, the stimulator 40is activated if the pressure sensors 32 detect grinding and/or clenchingby the user. According to an aspect, the stimulator 40 provideselectrical stimulus or an electrical field to reservoir(s) 42 asinstructed by microprocessor 50 acting in response to inputs from one ormore of sensors 30, 32, 34 and 36.

As illustrated in FIGS. 2-4, a microprocessor 50 may be provided onand/or embedded within the mouthpiece 20. As illustrated in FIGS. 2 and3, the microprocessor 50 may be positioned on or in the buccal portion23. Alternatively, and as illustrated in FIG. 4, the microprocessor 50may be positioned on or in the lingual portion 24 of the mouthpiece 20.In other words, it is possible to place the microprocessor 50 on themouthpiece 20 wherever available real estate may be found. Thus, whenmore than one component, such as, for example, the oxygen sensor 30 andthe stimulator 40, are positioned at the lingual portion 24 of themouthpiece 20, the microprocessor 50 may be positioned away from theseregions on the buccal portion 23. In some embodiments and as illustratedin FIG. 4, the microprocessor 50 is positioned at the lingual portion 24of the mouthpiece 20 and may be embedded therein. It is to be understoodthat the microprocessor 50 may be positioned at any location thatenables it to communicate with the components included in the oralappliance 10, such as, for example, the oxygen sensor 30, the pressuresensor 32, the airflow sensor 34, the noise detector 35, the actigraphysensor 36, the stimulator 40, the data recorder 60, and/or a battery 70,while ensuring that the location of the microprocessor 50 helps maintaina comfortable fit and/or maintain wearability of the mouthpiece 20 bythe user. The microprocessor 50 may be attached to and/or positioned atany desired location on the mouthpiece 20, such as, anteriorly,posteriorly and any location therebetween. According to an aspect, themicroprocessor 50 is sized and/or positioned to provide for acomfortable fit for the user. To be sure, the microprocessor 50 may bepositioned at any location that does not interfere with the comfortablefit of the mouthpiece 20 for the user. The microprocessor 50 may beconfigured to receive data corresponding to the actual oxygen saturationlevels of hemoglobin from the at least one oxygen sensor 30, and datarelating to the user's grinding and/or clenching behavior, actualairflow levels, actual noise and/or snoring levels. In an embodiment,the microprocessor 50 is configured to activate the stimulator 40 if theoxygen sensor 30 determines that the actual oxygen saturation level ofhemoglobin of the user is at a predetermined level. According to anaspect, the microprocessor 50 activates the stimulator 40 if thepressure sensor 32 determines that the user is clenching and/or grindinghis/her dentition at unacceptable levels. The microprocessor 50 mayactivate the stimulator 40 if the airflow sensor 34 determines that theuser's airflow rate is below the predetermined airflow level. Accordingto an aspect, the microprocessor 50 activates the stimulator if thenoise detector 35 determines that the user's actual noise and/orvibrations during sleep are above the predetermined noise level.

As illustrated in FIGS. 2-4 and in an embodiment, the oral appliance 10includes a data recorder 60. The data recorder 60 may be positioned at,for instance, the buccal portion 23 of the mouthpiece 20, (see, forinstance, FIG. 2). According to an aspect and as illustrated in FIG. 3,the data recorder 60 is positioned at the lingual portion 24 of themouthpiece 20. In an embodiment, the data recorder 60 is configured toreceive and/or store information provided from the microprocessor 50.According to an aspect, the data recorder 60 receives and/or stores theactual oxygen saturation level of hemoglobin, the predetermined forcelevel of the user applied to the occlusal and/or bite surfaces and/orthe predetermined airflow level, as provided by the oxygen sensor 30,the pressure sensors 32 and the airflow sensor 34, respectively. Thedata recorder 60 may also receive and/or store stimulation informationregarding the quantity and/or frequency of stimulations provided by thestimulator 40. The data recorder 60 may also store pharmaceuticalcompound dispensing information such as the volume/dosage ofpharmaceutical dispensed from reservoir(s) 42 at each dispensing eventand the total volume dispensed and, thus, remaining in reservoir(s) 42.This remaining pharmaceutical compound data may be used in signalinguser as to replacement of reservoir(s) 42.

According to an aspect, the appliance 10 includes a transceiver (notshown). The transceiver may be configured to remotely monitor anyadditional components provided on and/or within the mouthpiece 20. In anembodiment, the transceiver may be configured for use with a customizedweb-based application for a handheld wireless communication device. Thecustomized web-based application may include features such as, a graphof the user's sleep position and chart and/or graphical data related tooxygen saturation levels of hemoglobin and the pressure applied toocclusal surfaces of the user's dentition. According to an aspect, thecustomized web-based application may include data related to the user'sheart rate. In an embodiment, the transceiver communicates with handheldwireless communication devices having Bluetooth® capabilities. Thetransceiver may be communicable with handheld wireless communicationdevices, such as, for example, computers, smart watches, smart phones,and the like.

The oral appliance 10 may include a battery 70. While it is contemplatedthat the battery 70 is rechargeable, it may be disposable. The battery70 may be configured to provide power to at least one of the oxygensensor 30, the pressure sensor 32, the airflow sensor 34, the noisedetector 35, the actigraphy sensor 36, the stimulator 40, themicroprocessor 50, the data recorder 60 and the transceiver. Accordingto an aspect, the battery 70 includes an energy store and a contactelement sealably arranged on the mouthpiece 20 (not shown). In anembodiment, the battery 70 is embedded within the mouthpiece 20, suchthat the battery 70 is not exposed to liquids, saliva and/or oraltissue. The battery 70 may be positioned near the buccal portion 23(see, for instance, FIG. 2). According to an aspect, the battery 70 ispositioned near the lingual portion 24 (see, for instance FIG. 4) of themouthpiece 20.

As illustrated in FIG. 5, the oral appliance may include a data transferpod 80. The data transfer pod 80 may be configured to charge and/orprovide power to the rechargeable battery 70. According to an aspect thedata transfer pod 80 is configured to retrieve and/or store informationcollection by the data recorder 60, such that the user and or medicalprovider can track and/or assess the collected information. According toan aspect, the transceiver may include power amplifiers (not shown)configured to reduce power requirements of the oral appliance 10,thereby helping to conserve life of the rechargeable battery 70. Thedata transfer pod 80 may be provided with an electrical contactcomponent accessible to a plug of a power supply unit (not shown).

As illustrate in FIG. 5 and in an embodiment, an oral appliance kit 100for treatment of sleep apnea in a user is provided. In an embodiment,the oral appliance kit 100 includes the oral appliance 10, including thevarious electronic components, as substantially described above andillustrated in FIGS. 2-4, and the data transfer pod 80.

FIG. 6 is a flowchart illustrating an exemplary operation 200 of theoral appliance 10. Optionally, a customized mouthpiece is created 201and various electronic components are assembled to form the oralappliance. The mouthpiece of the oral appliance is positioned 210 in theuser's oral cavity. Oxygen sensors measure 220 oxygen saturation levelsof the users hemoglobin, pressure sensors measure 222 the pressureapplied to occlusal surfaces of the customized mandibular mouthpiece,airflow sensors measure 224 the actual airflow and/or breathing rate ofthe user, actigraphy sensors measure 226 data related to sleep activity,including sleep position and movement of the user during sleep and/ornoise detectors measure 228 the actual noise and/or vibrations createdby the user during sleep. The microprocessor collects, records andanalyzes data 230 relating to oxygen saturation, pressure, airflow,sleep activity and actual noise levels. In the event that actual oxygensaturation levels of hemoglobin are below a predetermined level or inthe event that the actual pressure applied to the occlusal portion ofthe mouthpiece is above the predetermined pressure level, the stimulatorsends impulses 240 to stimulate the genioglossus muscle of the user'stongue. The oxygen sensors re-measure 250 the oxygen saturation level ofhemoglobin, the pressure sensor re-measures 252 the pressure applied toocclusal surfaces of the customized mandibular mouthpiece, the airflowsensors re-measure 254 actual airflow of the user, the actigraphysensors re-measure 256 the user's sleep activity, and the noise detectorre-measures 258 the actual noise and/or vibrations created by the userduring sleep. Stimulation is stopped if the predetermined levels areachieved. According to an aspect If the predetermined levels are notachieved, stimulation continues, increases, decreases or otherwisevaries according to the measured values.

According to an aspect, an upper mouthpiece 120 is configured to besecured to/worn on the user's upper dentition. As illustrated in FIG. 7,the mouthpiece 120 includes dentition attachment members 128 (orcollectively, a dentition attachment portion 128 which has a generallyarch shape of an upper dentition). The dentition attachment portion 128has a buccal surface/wall 130 a facing the user's lips and/or cheeks,and a lingual surface/wall 130 b opposite the buccal surface 130 afacing the user's tongue. The mouthpiece 120 further includes a palateportion 122 adjacent to and integrally connected with the lingualsurface 130 b of the dentition attachment portion 128. The mouthpiece120 also includes a gum portion 132 (shown in FIGS. 8A-9) integral withand extending upwardly from the buccal surface 130 a of the dentitionattachment portion 128, such that the gum portion 132 lies along theuser's upper gum adjacent to the user's maxillary bone. The dentitionattachment portion 128, palate portion 122, and gum portion 132 areintegral parts of a unitary body.

The gum portion 132, dentition attachment portion 128, and mouthpiece120 overall can each be described (when viewed in top plan view) ashaving a left side/portion/wing 134 a (i.e., generally positioned on theuser's left dentition), a right side/portion/wing 134 b (i.e., generallypositioned on the user's right dentition), an anterior portion or end136 a (i.e., generally positioned on the user's front/anteriordentition), and a posterior portion or end 136 b (i.e., generallypositioned on the user's back/posterior dentition). The palate portion122 thus extends between and is partially surrounded by the left side ofthe dentition attachment portion and the right side of the dentitionattachment portion.

As shown in FIG. 7, the dentition attachment members 128 (each andcollectively) have a shape and size that substantially conforms to theupper dentition of the user. The palate portion 122 of the uppermouthpiece 120 substantially conforms to the palate of the user. Thus,the user is presented with a mouthpiece 120 having a secured andcustomized fit. The dentition attachment members 128 may be providedwith a wire-frame form for support or, as shown in FIG. 7, support maystem from the presence of the palate portion 122 and the material chosenfor forming the upper mouthpiece 120. According to an aspect, a portionof the dentition attachment members 128 may be shaped to form aretention loop around one or more teeth of the user. The dentitionattachment members 128 and palate portion 122 render the uppermouthpiece 120 capable of being at least temporarily fixed in place byvirtue of the customized fit. As such, the mouthpiece 120 may provide aretention function thereby allowing it to remain in place during theuser's sleep, particularly in situations where the user may make slightto moderate movements during sleep and/or when the user may be awake.

Thus, the mouthpiece 120 may be substantially immovable unless positiveeffort is applied to remove the mouthpiece 120. In other words, the usermay remove the mouthpiece 120 at any time, if desired, by exerting alittle pressure to remove the mouthpiece 120. Since the mouthpiece 120is not permanently affixed to the dentition, it can be worn and/orsubsequently removed by the user at any time.

As with mouthpiece 20, components may be positioned on and/or embeddedwithin the upper mouthpiece 120. Components in or on the uppermouthpiece 120 may include any of the components associated with themouthpiece 20. The components illustrated in FIG. 7 include a first pairof electrodes 112 a, 112 b, a second pair of electrodes 114 a, 114 b, amicroprocessor 118 and electrical leads 116 connecting each electrode tothe microprocessor 118. The microprocessor 118 may have a data recorder60 and/or a battery 70 associated and integral therewith that can beembedded within the upper mouthpiece 120, such that any component on anysurface of mouthpiece 120 is covered to eliminate tissue damage anddamage to the components. Placement of the components should notinterfere with the fit of the upper mouthpiece 120 in the user's mouthor irritate user's gums or palate. Electrical leads 116 are also eitherembedded in the material of the mouthpiece 120 or, if placed on thesurface of the mouthpiece, covered to eliminate a number of readilyapparent issues with loose leads. FIG. 9 illustrates how the electricalleads 116 follow the shape of the upper mouthpiece 120, either within oron top of the mouthpiece material, from each electrode to themicroprocessor 118.

The microprocessor 118 of the upper mouthpiece 120 may also be providedwith a wireless transceiver that enables it, like the oral appliance 10,to communicate with external wireless communication devices, such as,for example, computers, smart watches, smart phones, and the like. Inaddition, the wireless transceivers of the upper mouthpiece 120 and oralappliance 10 may communicate with one another. Thus, microprocessor 118of the upper mouthpiece 120 may supply information to the oral appliance10 is much the same way that the oral appliance receives informationfrom external sources as well as its constituent components.Alternatively, it is contemplated that the upper mouthpiece 120 and oralappliance 10 may be wired together in a manner that would not beinconvenient or uncomfortable to the user.

FIG. 7 shows an arrangement where the first electrode pair 112 a, 112 b,the second electrode pair 114 a, 114 b and microprocessor 118 are alllocated in or on the palate portion 122 of the upper mouthpiece 120.Electrical leads 116 convey the electrical signals from each of theelectrodes 112 a, 112 b, 114 a, 114 b to the microprocessor 118.Although there is ample room toward the posterior portion of the uppermouthpiece 120 palate portion 122, it may be difficult to obtain astrong electroencephalograph signal when electrodes are positionedsolely underneath the palate portion.

FIGS. 8A and 8B show an arrangement where the first electrode pair 112a, 112 b and the second electrode pair 114 a, 114 b are located on thegum portion 132 of the upper mouthpiece 120 adjacent the buccal side ofthe maxillary bone of the user. That is, the first electrode pair 112 a,112 b and the second electrode pair 114 a, 114 b are located between theupper gums and inner lip/cheek of the user. The upper jaw, whichincludes the maxillary bone of the user, is a continuous extension ofthe skull bone, i.e., on the underside of the brain. Thus, electrodes inintimate contact with the upper jawbone (i.e., the bone in contact withthe inside of the cheeks and upper lip of the user), on the buccal side,of the user will receive brain waves in the same manner as the scalp.Electrodes 112 a and 114 a (e.g., the left side electrodes) arepositioned along the left side of the gum portion 132/mouthpiece 120(i.e., along the left buccal side of the maxillary bone of the user) andtheir paired electrodes 112 b and 114 b (e.g., the right sideelectrodes) are positioned along the right side of the gum portion132/mouthpiece 120 (i.e., along the right buccal side of the maxillarybone of the user). The locations of the electrodes in FIGS. 8A and 8Bpermit a good EEG signal, which can be clearly read and interpreted, tobe achieved by the electrodes and microprocessor 118. The microprocessor118, though it cannot be seen in FIGS. 8A and 8B, may be located in oron the palate portion 122 of the upper mouthpiece 120, i.e., inapproximately the same location on the palate portion 122 as in FIG. 7.Electrical leads 116 convey the electrical signals from each of theelectrodes 112 a, 112 b, 114 a, 114 b to the microprocessor 118 by themost direct route along or within the material of upper mouthpiece 120.For example, the electrical leads 116 may follow the contour of thedentition attachment member 128 down, over and then up to the palateportion 122, where the electrical leads 116 then proceed to themicroprocessor 118. The path of the electrical leads in FIGS. 8A and 8Bare similar to those in FIG. 9, and FIG. 9 illustrates these paths moreclearly.

FIG. 9 shows an arrangement where the first electrode pair 112 a, 112 band the second electrode pair 114 a, 114 b are, like in FIGS. 8A and 8B,located on the gum portion 132 of upper mouthpiece 120 adjacent thebuccal side of the maxillary bone of the user. Electrodes 112 a and 114a (e.g., the posterior electrodes) are positioned along the posteriorportion of the gum portion 132 (and the mouthpiece 120) and their pairedelectrodes 112 b and 114 b (e.g., the anterior electrodes) arepositioned along the anterior portion of the gum portion 132 (and themouthpiece 120). The locations of the electrodes in FIG. 9 permit a goodEEG signal to be achieved by the electrodes and microprocessor 118. Themicroprocessor 118, though it cannot be seen in FIG. 9, is located in oron the palate portion 122 of the upper mouthpiece 120, i.e., inapproximately the same location on the palate portion 122 as in FIG. 7.Electrical leads 116 convey the electrical signals from each of theelectrodes 112 a, 112 b, 114 a, 114 b to the microprocessor 118 by themost direct route along or within the material of upper mouthpiece 120.That is, the electrical leads 116 will follow the contour of thedentition attachment members 128 down, over and then up to the palateportion 122, where the electrical leads 116 then proceed to themicroprocessor 118.

With any of the electrode arrangements of electrodes shown in FIGS. 7,8A, 8B and 9, each of first electrode pair 112 a, 112 b and secondelectrode pair 114 a, 114 b may, along with the microprocessor 118,comprise an electroencephalograph of sufficient sensitivity to detectrhythm changes in electrical signals in the brain. The electrodes 112 a,112 b and 114 a, 114 b register voltage differences between the paired“a” electrode and “b” electrode generated by electrical signals in thebrain. The signals detected by the electrodes are provided, via theelectrical leads 116, to a signal processor that is part of themicroprocessor 118.

As with any electroencephalograph, some mental/consciousness statesresult in the voltage differences detected between first electrode pair112 a, 112 b and the second electrode pair 114 a, 114 b being rhythmic,shown as waves on a graph by the recording channel. The EEG signal forconscious adult in a relaxed state will typically be an oscillating waveknown as an alpha wave. A sleeping adult's brain waves become extremelyslow. These slow waves are referred to as delta waves and may beutilized not only to identify sleep but also to assess the depth ofsleep. That is, varying strength of the delta waves can be indicative ofa deeper sleep state. The signal processor and other microprocessor 118components are able to differentiate various EEG rhythms and todetermine, based on these detected rhythms, the various consciousnessand sleep states of the user. It is contemplated that the mouthpiece 120may be able diagnose epilepsy by way of recording the user's brainactivity—such brain activity may be collected by the data recorder 60.

FIG. 10 is a flowchart illustrating an exemplary operation 300 of theupper mouthpiece 120 in cooperative communication with the oralappliance 10. Optionally, a customized upper mouthpiece 120 and oralappliance 10 mouthpiece are created 201 and various electroniccomponents are assembled to form the full cooperative appliance. Theupper mouthpiece 120 and mouthpiece portion of oral appliance 10 arepositioned 210 in the user's oral cavity. The first electrode pair 112a, 112 b and the second electrode pair 114 a, 114 b collect voltage dataand the microprocessor assesses an EEG rhythm 212 from this data. Theupper mouthpiece microprocessor 118 may utilize the EEG rhythm to assessthe sleep state 214 of the user and a determination of sleep state iscommunicated to the oral appliance 10. Alternatively, the raw EEG rhythmmay be communicated to the oral appliance 10 for assessment at step 230.In the event that the EEG data indicates that the user may be having anarousal from sleep or has exited a sleep state in an untimely manner,the microprocessor of the oral appliance may cause the stimulator tosend impulses 240 to stimulate the genioglossus muscle of the user'stongue. The upper mouthpiece 120 is constantly assessing the EEG rhythms262 and sleep state 264 of the user and providing data to the oralappliance. Stimulation is stopped if the appropriate sleep states areachieved. According to an aspect, if the predetermined EEG rhythms arenot regained, stimulation continues, increases, decreases or otherwisevaries according to the measured values.

The flowchart shown in FIG. 10 may be utilized independently of or incombination with the flowchart shown in FIG. 6. Thus, the EEG data maybe used in combination with or supplemental to oxygen sensors measure220, pressure sensors measure 222, airflow sensors measure 224,actigraphy sensors measure 226 and/or noise detectors measure 228.

The various upper mouthpieces described above (e.g., upper mouthpiece120 described in connection with FIGS. 7, 8A, 8B, and 9) may find use ina variety of other applications. For example, the mouthpiece may be amouthguard suitable for use in athletic activities. In such anapplication, the mouthpiece may be used to assess potential medicalconditions or injuries, such as concussions or other head trauma. Thedata and/or results can be delivered via Bluetooth to a smart device orcan be delivered to a remote application via the internet (e.g., a cloudapplication). Other possibilities are contemplated, as will beunderstood by those of skill in the art. Such data may also be useful ingenerally studying head trauma that occurs in athletics.

As another example, the various upper mouthpieces may find use inhobbyist or gaming applications, such as personal meditation devices,virtual reality games, video games, learning/educational devices, orother personal activities that center around brain activity.

The upper mouthpieces may be used with or without a lower mouthpiece,such as mouthpiece 10.

The components of the apparatus illustrated are not limited to thespecific embodiments described herein, but rather, features illustratedor described as part of one embodiment can be used on or in conjunctionwith other embodiments to yield yet a further embodiment. It is intendedthat the apparatus include such modifications and variations. Further,steps described in the method may be utilized independently andseparately from other steps described herein.

While the apparatus and method have been described with reference tospecific embodiments, it will be understood by those skilled in the artthat various changes may be made and equivalents may be substituted forelements thereof without departing from the scope contemplated. Inaddition, many modifications may be made to adapt a particular situationor material to the teachings found herein without departing from theessential scope thereof.

In this specification and the claims that follow, reference will be madeto a number of terms that have the following meanings. The singularforms “a,” “an” and “the” include plural referents unless the contextclearly dictates otherwise. Furthermore, references to “one embodiment”,“some embodiments”, “an embodiment” and the like are not intended to beinterpreted as excluding the existence of additional embodiments thatalso incorporate the recited features. Approximating language, as usedherein throughout the specification and claims, may be applied to modifyany quantitative representation that could permissibly vary withoutresulting in a change in the basic function to which it is related.Accordingly, a value modified by a term such as “about” is not to belimited to the precise value specified. In some instances, theapproximating language may correspond to the precision of an instrumentfor measuring the value. Terms such as “first,” “second,” “upper,”“lower” etc. are used to identify one element from another, and unlessotherwise specified are not meant to refer to a particular order ornumber of elements.

As used herein, the terms “may” and “may be” indicate a possibility ofan occurrence within a set of circumstances; a possession of a specifiedproperty, characteristic or function; and/or qualify another verb byexpressing one or more of an ability, capability, or possibilityassociated with the qualified verb. Accordingly, usage of “may” and “maybe” indicates that a modified term is apparently appropriate, capable,or suitable for an indicated capacity, function, or usage, while takinginto account that in some circumstances the modified term may sometimesnot be appropriate, capable, or suitable. For example, in somecircumstances an event or capacity can be expected, while in othercircumstances the event or capacity cannot occur—this distinction iscaptured by the terms “may” and “may be.”

As used in the claims, the word “comprises” and its grammatical variantslogically also subtend and include phrases of varying and differingextent such as for example, but not limited thereto, “consistingessentially of” and “consisting of” Where necessary, ranges have beensupplied, and those ranges are inclusive of all sub-ranges therebetween.It is to be expected that variations in these ranges will suggestthemselves to a practitioner having ordinary skill in the art and, wherenot already dedicated to the public, the appended claims should coverthose variations.

Advances in science and technology may make equivalents andsubstitutions possible that are not now contemplated by reason of theimprecision of language; these variations should be covered by theappended claims. This written description uses examples to disclose themethod, machine and computer-readable medium, including the best mode,and also to enable any person of ordinary skill in the art to practicethese, including making and using any devices or systems and performingany incorporated methods. The patentable scope thereof is defined by theclaims, and may include other examples that occur to those of ordinaryskill in the art. Such other examples are intended to be within thescope of the claims if they have structural elements that do not differfrom the literal language of the claims, or if they include equivalentstructural elements with insubstantial differences from the literallanguage of the claims.

What is claimed is:
 1. A mouthpiece for detecting electrical activity in a user's brain, the mouthpiece comprising: a dentition attachment portion for receiving an upper dentition of the user, the dentition attachment portion having a buccal surface; a gum portion extending upwardly from the buccal surface of the dentition attachment members, such that the gum portion lies along an upper gum of the user; electrodes positioned along the gum portion of the mouthpiece; and a microprocessor connected to the electrodes, wherein the electrodes and microprocessor are operative for detecting electrical activity in the user's brain.
 2. The mouthpiece of claim 1, wherein the electrodes are embedded within the gum portion of the mouthpiece.
 3. The mouthpiece of claim 1, wherein the gum portion has a left side and a right side, and wherein the electrodes comprise a first pair of electrodes, the first pair of electrodes including a left side electrode positioned along the left side of the gum portion and a right side electrode positioned along the right side of the gum portion.
 4. The mouthpiece of claim 3, wherein the electrodes further comprise a second pair of electrodes, the second pair of electrodes including a left side electrode positioned along the left side of the gum portion and a right side electrode positioned along the right side of the gum portion.
 5. The mouthpiece of claim 1, wherein the gum portion has an anterior portion and a posterior portion, and wherein the electrodes comprise a first pair of electrodes, the first pair of electrodes including an anterior electrode positioned along the anterior portion of the gum portion and a posterior electrode positioned along the posterior portion of the gum portion.
 6. The mouthpiece of claim 5, wherein the electrodes further comprise a second pair of electrodes, the second pair of electrodes including an anterior electrode positioned along the anterior portion of the gum portion and a posterior electrode positioned along the posterior portion of the gum portion.
 7. The mouthpiece of claim 1, wherein the dentition attachment portion has a lingual surface opposite the buccal surface, and wherein the mouthpiece further comprises a palate portion extending from the lingual surface of the dentition attachment portion.
 8. The mouthpiece of claim 7, wherein the microprocessor is disposed along the palate portion of the mouthpiece.
 9. The mouthpiece of claim 1, further comprising electrical leads connecting the electrodes to the microprocessor.
 10. The mouthpiece of claim 1, comprising a mouthguard for an athletic activity.
 11. The mouthpiece of claim 1, comprising a mouthpiece for a gaming activity.
 12. A mouthpiece for detecting electrical activity in a user's brain, the mouthpiece comprising: a dentition attachment portion configured to conform to at least a portion of an upper dentition of the user; a palate portion integral with the dentition attachment portion, the palate portion being configured to conform to at least a portion of a palate of the user; a gum portion integral with the dentition attachment portion, the gum portion being configured to conform to at least a portion of a gum of the user; a plurality of electrodes positioned along the gum portion; and a microprocessor connected to the electrodes, wherein the electrodes and microprocessor are operative as an electroencephalograph for detecting electrical activity in the user's brain.
 13. The mouthpiece of claim 12, wherein the dentition attachment portion has a buccal surface, and the gum portion extends from the buccal surface of the dentition attachment portion.
 14. The mouthpiece of claim 12, wherein the plurality of electrodes includes pairs of electrodes, and for each pair of electrodes, a first electrode is positioned along a left side of the gum portion and a second electrode is positioned along a right side of the gum portion.
 15. The mouthpiece of claim 12, wherein the plurality of electrodes includes pairs of electrodes, and for each pair of electrodes, a first electrode is positioned along an anterior portion of the gum portion and a second electrode is positioned along a posterior portion of the gum portion.
 16. The mouthpiece of claim 12, wherein the microprocessor is embedded within the palate portion of the mouthpiece.
 17. A mouthpiece for detecting electrical activity in a user's brain, the mouthpiece comprising: a dentition attachment portion for being positioned on an upper dentition of the user, the dentition attachment portion having a buccal surface and a lingual surface; a gum portion extending from the buccal surface of the dentition attachment portion, so that the gum portion lies along an upper gum of the user; a palate portion extending from the lingual surface of the dentition attachment portion; a plurality of pairs of electrodes positioned along the gum portion; and a microprocessor connected to the plurality of pairs of electrodes, wherein the microprocessor connected to the plurality of pairs of electrodes is operative as an electroencephalograph.
 18. The mouthpiece of claim 17, wherein for each pair of electrodes, a first electrode is positioned along a left side of the gum portion and a second electrode is positioned along a right side of the gum portion.
 19. The mouthpiece of claim 17, wherein for each pair of electrodes, a first electrode is positioned along an anterior portion of the gum portion and a second electrode is positioned along a posterior portion of the gum portion.
 20. The mouthpiece of claim 17, wherein the microprocessor is embedded within the palate portion of the mouthpiece. 